# FDA WARNING_LETTER - Emmett F. Branigan, MD, PS, Inc - January 31, 2018

Source: https://www.keypedia.com/records/warning_letter/emmett-f-branigan-md-ps-inc/fd95d190-aa77-415b-b049-676d1ad50ca3

> FDA WARNING_LETTER for Emmett F. Branigan, MD, PS, Inc on January 31, 2018. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Emmett F. Branigan, MD, PS, Inc
- Inspection Date: 2018-01-31
- Product Type: Biologics
- Office Name: Los Angeles District Office
- Summary: The FDA inspected Emmett F. Branigan, MD, PS, Inc. from January 29-31, 2018, identifying significant deviations from HCT/P regulations (21 CFR 1271). Key violations include:

1.  **Failure to test for communicable disease agents (21 CFR 1271.85(a))**: An anonymous oocyte donor was deemed eligible without required Chlamydia, Neisseria gonorrhea, HIV-1/HBV/HCV, and WNV NAT testing.
2.  **Failure to screen for relevant communicable disease agents (21 CFR 1271.75(a))**:
    *   The "Donor Medical History Interview" form lacked questions to assess Zika virus risk, and multiple donors were not screened for ZIKV.
    *   Relevant medical records ("Donor Physical Assessment Form," "Donor Physical Assessment Form (A)," and "Donor Medical History Interview") were incomplete for an oocyte donor before eligibility determination.
3.  **Failure to determine and document donor eligibility (21 CFR 1271.50(a))**: A responsible person failed to sign the "Donor Eligibility Determination Form" for an oocyte donor.
4.  **Failure to establish and maintain procedures for donor eligibility (21 CFR 1271.47(a))**:
    *   The "Donor Medical

## Related Officers

- [Emmett F. Branigan](https://www.keypedia.com/people/emmett-f-branigan/2719cd48-8b3a-439d-99c3-1938cd724756)
- [Program Division Director](https://www.keypedia.com/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.keypedia.com/companies/emmett-f-branigan-md-ps-inc/ee3dad29-7354-47cf-b787-f641dcbe9543

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b